Patient Medication Information: uses, side effects, how to take - PMS-Clobazam
Serious Warnings and Precautions
Addiction, Abuse and Misuse: Even if you take pms-CLOBAZAM exactly as you were told to, you are at risk for abuse, misuse, addiction, physical dependence and withdrawal. Abuse and misuse can result in overdose or death, especially if you take pms-CLOBAZAM with:
Your doctor should:
Store pms-CLOBAZAM in a secure place to avoid theft or misuse. Withdrawal: If you suddenly stop taking pms-CLOBAZAM, lower your dose too fast, or switch to another medication, you can experience severe or life-threatening withdrawal symptoms (see Other warnings you should know about)
pms-CLOBAZAM with Opioids: Taking pms-CLOBAZAM with opioid medicines can cause:
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What is pms-CLOBAZAM used for?
pms-CLOBAZAM is used as add-on therapy in patients whose epilepsy is not well controlled on their current antiepileptic drugs.
If you are 65 years or older, talk to your doctor before starting pms-CLOBAZAM. pms-CLOBAZAM may not be an effective treatment for you and you may be more sensitive to experiencing side effects.
How does pms-CLOBAZAM work?
pms-CLOBAZAM belongs to the family of medicines called anticonvulsants. It acts in the brain to block the spread of seizure activity.
What are the ingredients in pms-CLOBAZAM?
Medicinal ingredients: Clobazam.
Non-medicinal ingredients: Colloidal silicon dioxide, Corn starch, Croscarmellose sodium, Lactose anhydrous, Magnesium stearate and Talc.
pms-CLOBAZAM comes in the following dosage forms:
Tablet: 10 mg
Do not use pms-CLOBAZAM if you or your child:
- are allergic to the active ingredient clobazam or any of the other ingredients
- have been diagnosed with myasthenia gravis
- have narrow angle glaucoma (increased pressure in your eye)
have any history of drug or alcohol dependence
- have severe difficulty breathing
- have sleep apnea (pauses in breathing during sleep)
- have severe liver problems
are in the 1st trimester (first 3 months) of pregnancy. Avoid becoming pregnant while taking pms-CLOBAZAM. Effective birth control methods must be used, Tell your healthcare professional right away if you become pregnant during treatment or plan to get pregnant.
- are breast-feeding. If you are breastfeeding, you should stop before starting treatment with pms-CLOBAZAM since clobazam passes into breast milk.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you or your child take pms-CLOBAZAM. Talk about any health conditions or problems you or your child may have, including if you:
- Have ever had a rash or unusual reaction while taking clobazam or any other antiepileptic drug.
- Are over the age of 65 or debilitated (in a weakened state).
- Have been diagnosed with decreased mental function due to a medical disease.
- Use alcohol or drugs. Do not drink alcohol while you are taking pms-CLOBAZAM.
- Have a history of drug or alcohol abuse. If you are dependent on drugs or alcohol, pms-CLOBAZAM may increase your dependence.
- Have a history of mental illness, depression, and/or suicide attempts. pms-CLOBAZAM increases the risk of suicidal thoughts or worsening of depression.
- Have kidney or liver problems. Your healthcare professional may need to adjust the dose.
- Have breathing problems.
- Have muscle weakness and/or spinal /cerebellar ataxia (sudden uncoordinated movements).
Are pregnant or planning to become pregnant. pms-CLOBAZAM is not to be used in the first trimester of pregnancy and must only be taken in the later stages if your healthcare professional tells you to.
- If you become pregnant while taking pms-CLOBAZAM, talk to your healthcare professional about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. You can enroll in this registry by calling 1-888-233-2334. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.
- Are in labour. Taking pms-CLOBAZAM immediately before or during childbirth may have an effect on the newborn.
- Have difficulty forming new memories (anterograde amnesia). Anterograde amnesia is known to occur even if antiepileptics are used in the normal dose range, but especially at higher dose levels. Amnesia effects may be associated with inappropriate behaviour.
- Have been taking pms-CLOBAZAM for a long time. It may not work as well as it used to.
Are taking birth control.
- pms-CLOBAZAM may make hormonal birth control such as “the pill” less effective.
- Use other forms of safe and effective birth control when talking pms-CLOBAZAM.
- You need to use other forms of birth control until the end of your menstrual cycle after stopping treatment.
have ever had a problem with:
- substance use, including prescribed or illegal drugs, or
- alcohol
- have ever had seizures or convulsions (violent uncontrollable shaking of the body with or without loss of consciousness)
Other warnings you should know about:
Severe Skin Reactions:
pms-CLOBAZAM can cause serious life-threatening skin reactions, such as:
- Stevens-Johnson Syndrome (SJS)
- Toxic Epidermal Necrolysis (TEN) and
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
These skin reactions can spread to your mouth, lips, face, hands, trunk (torso), arms and legs. Stop taking pms-CLOBAZAM and contact your healthcare professional right away if you or your child experiences:
- fever
- severe rash
- peeling skin
- swollen lymph glands
- flu-like feeling
- yellow skin or eyes
- shortness of breath
- dry cough
- chest pain or discomfort
- feeling thirsty
- urinating less often, less urine
Driving and using machines: Before doing tasks that require special attention, wait until you know how you respond as pms-CLOBAZAM can cause drowsiness, dizziness and muscle weakness.
- Do not suddenly stop taking pms-CLOBAZAM. Always follow your healthcare professional’s instructions. Stopping this drug quickly may lead to an increase in seizure activity or withdrawal symptoms, such as headaches, trouble sleeping, anxiety, confusion and irritability.
Withdrawal: If you suddenly stop your treatment, lower your dose too fast, or switch to another medication, you can experience withdrawal symptoms that can range from mild symptoms to severe or life threatening. Some of your withdrawal symptoms can last for months after you stop pms-CLOBAZAM.
Your risk of going through withdrawal is higher if you are taking pms-CLOBAZAM for a long time or at high doses. However, symptoms can still occur if you are taking pms-CLOBAZAM as directed for a short period of time or slowly reducing the dose.
The symptoms of withdrawal often resemble the condition that you are being treated for. After stopping your treatment, it may be hard to tell if you are experiencing withdrawal or a return of your condition (relapse).
Tell your doctor right away if you experience any symptoms of withdrawal after changing or stopping your treatment.
Severe symptoms of withdrawal include:
- feeling like you cannot move or respond (catatonia)
- severe confusion, shivering, irregular heartrate and excessive sweating (delirium tremens)
- feeling depressed
- feeling disconnected from reality (dissociation)
- seeing or hearing things that are not there (hallucinations)
- overactive behaviour and thoughts (mania)
- believing in things that are not true (psychosis)
- convulsions (seizures), including some that do not stop
- thoughts or actions of suicide
For other symptoms of withdrawal, see the Serious side effects and what to do about them table (below).
To reduce your chances of going through withdrawal:
- always contact your doctor before stopping or reducing your dose of pms-CLOBAZAM or changing medications
- always follow your doctor’s instructions on how to reduce your dose carefully and safely
- tell your doctor right away if you experience any unusual symptoms after changing or stopping your treatment
pms-CLOBAZAM with Opioids: Taking pms-CLOBAZAM with opioid medicines can cause severe drowsiness and breathing problems.
Tell your doctor if you:
- are taking opioid medicines
- are prescribed an opioid medicine after you start taking pms-CLOBAZAM
Do NOT drive or operate heavy machinery or do tasks that require special attention until you know how taking an opioid medicine and pms-CLOBAZAM affects you.
Falls and Fractures: Benzodiazepines like pms-CLOBAZAM can cause you to feel sleepy, dizzy and affect your balance. This increases the risks of falling, which can cause fractures or other fall related -injuries, especially if you:
- take other sedatives
- consume alcohol
- are elderly or
- have a condition that causes weakness or frailty
DURING treatment with pms-CLOBAZAM, tell your healthcare professional if you or your child develops:
- Thoughts of suicide or self-harm
Tell your healthcare professional about all the medicines you or your child take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions Taking pms-CLOBAZAM and opioids may cause:
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The following may interact with pms-CLOBAZAM:
- Hormonal birth control (such as “the pill”).
- Other antiepileptic drugs (such as carbamazepine, phenytoin, valproate, phenobarbital).
- Drugs used to treat fungal infections (such as fluconazole).
- Antidepressant medications (such as fluvoxamine).
- Ticlopidine, used to prevent blood clots and help prevent strokes and heart attacks.
- Omeprazole used to reduce stomach acid.
- Other drugs that affect your nervous system (such as antipsychotics, antihistamines that make you drowsy, anesthetics, other sedatives such as sleeping pills).
- Lithium used to treat bipolar disease.
- Narcotics (strong pain medications). Increased addiction can occur.
- Muscle relaxants and nitrous oxide (products often used in surgery or during dental procedures). pms-CLOBAZAM can prolong the effects.
- Alcohol.
How to take pms-CLOBAZAM:
pms-CLOBAZAM is a tablet to be taken by mouth. The tablets can be taken whole, or broken in half along the score line.
Always follow your healthcare professional’s instructions. Do not change the prescribed dose yourself. If you think the effect of your medicine is too weak or too strong, talk to your healthcare professional.
Your doctor will slowly decrease your dose and will tell you when to stop taking the medicine. Always follow your doctor’s instructions on how to lower your dose carefully and safely to avoid experiencing withdrawal symptoms.
Do not stop taking pms-CLOBAZAM without talking to your healthcare professional. Stopping a seizure medicine suddenly can cause serious problems, including seizures that will not stop. Your healthcare professional will tell you if and when you or your child can stop taking this medicine.
If the daily dose of pms-CLOBAZAM is to be divided, the higher portion should be taken at night (up to 30 mg may be taken as a single dose at night).
If you or your child are taking pms-CLOBAZAM for an extended period of time, your healthcare professional will perform regular blood tests for liver, kidney and thyroid function.
Usual dose:
Adults: The starting dose is 5-15 mg/day increasing gradually to a maximum daily dose of 80 mg/day, if needed.
Children from 2 to 16 years: The starting dose is 5 mg/day, which can be increased at 5- day intervals to a maximum daily dose of 40 mg/day, if needed.
Infants (˂2 years): The dose is based on body weight and will be determined by your healthcare professional.
Elderly patients (>65 years), patients with kidney, liver or breathing problems, muscle weakness or dizziness and unsteadiness when walking (spinal or cerebellar ataxia) and patients who are poor metabolizers of antiepileptic drugs (CYP2C19 poor metabolizers) may require lower doses.
Overdose:
| If you think you, or a person you are caring for, have taken too much pms-CLOBAZAM, contact a healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms. |
If you or your child have taken too large a dose of pms-CLOBAZAM, you may become drowsy, confused, and sluggish. You may have trouble walking, reacting, breathing, staying awake, or have low blood pressure. A coma or death is possible. Taking alcohol or other drugs that affect your nervous system at the same time as pms-CLOBAZAM increases the risk of death. When too much pms-CLOBAZAM wears off, you could be excited and jittery.
Missed Dose:
If you or your child misses a dose of pms-CLOBAZAM, take it as soon as you remember. If you are close to your next dose, just take your next dose, without making up for the missed dose. Do not take 2 doses at the same time.
What are possible side effects from using pms-CLOBAZAM?
These are not all the possible side effects you or your child may feel when taking pms-CLOBAZAM. If you or your child experience any side effects not listed here, contact your healthcare professional. Please also see WARNINGS AND PRECAUTIONS.
The most common side effects associated with the use of pms-CLOBAZAM are:
- Sleepiness/drowsiness, feeling tired/fatigue
- Dizziness
Common side effects include:
- Loss of coordination
- Nervousness
- Blurred vision
- Weight increase
Other side effects include:
- Headache
- Shakiness, tremor
- Slowed reaction time, muscle weakness
- Confusion, disorientation, trouble speaking, trance, diminished responsiveness
- Constipation, changes in appetite, nausea, vomiting, bloating, dry mouth, trouble swallowing
- Drooling
- Difficulty passing urine, bladder infection
- Fever
- Lower than normal body temperature
- Nasal congestion (blocked nose)
- Rash
- Falls and fractures
The following side effects occur after taking pms-CLOBAZAM for a long time or at high doses, but they can be reversed: Slowed or slurred speech, unsteady walking and other muscle functions, vision problems, weight gain, and loss of sexual desire.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| COMMON | |||
| Difficulty falling asleep or staying asleep | ✓ | ||
| Psychiatric Disorders (symptoms like irritability, mood swings, restlessness, anxiety, aggressiveness, fits of rage, delusions, changes in thinking) | ✓ | ||
| Nightmares | ✓ | ||
| Hallucinations: See and hear things that are not there | ✓ | ||
| Thoughts of suicide or self-harm | ✓ | ||
| Frequent Muscle Spasms | ✓ | ||
| Pneumonia/Aspiration Pneumonia Bronchitis (symptoms like cough, fever, difficulty breathing, chills) | ✓ | ||
| RARE | |||
| Serious Skin Reactions (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis): Any combination of itchy skin rash, redness, blistering and peeling of the skin and/or of the lips, eyes, mouth, nasal passages, or genitals. You may also get fever, sore throat, fatigue, chills, headache, cough, body aches or joint pain. | ✓ | ||
| VERY RARE | |||
Allergic reactions:
| ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| |||
| UNKNOWN | |||
| Altered numbers and types of blood cells (symptoms like unexplained tiredness, weakness, shortness of breath, and sometimes, feeling like you are going to pass out, increased bruising, nosebleeds, sore throats, or infections) | ✓ You should tell your healthcare professional who may want to perform a blood test | ||
| Anterograde Amnesia (symptoms like loss of the ability to create new memories, inappropriate behaviour) | ✓ | ||
| Respiratory depression (symptoms like shallow slow, weak breathing) | ✓ | ||
| Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) (serious skin reaction that may affect more than one organ): fever, severe rash, peeling skin, swollen lymph glands, flu-like feeling, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feel thirsty, urinating less often, less urine | ✓ | ||
| Overdose: extreme sleepiness, confusion, slurred speech, slow reflexes, slow shallow breathing, coma, loss of balance and coordination, uncontrolled rolling of the eyes, and low blood pressure. | ✓ | ||
| Respiratory Depression: slow, shallow or weak breathing. | ✓ | ||
Withdrawal: Severe symptoms include: Catatonia: feeling like you cannot move or respond Delirium Tremens: severe confusion, shivering, irregular heartrate and excessive sweating | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases |
|---|---|
Feeling depressed Dissociation: feeling disconnected from reality Hallucinations: seeing or hearing things that are not there Mania: overactive behaviour and thoughts Psychosis: believing in things that are not true Convulsions: (seizures – including some that do not stop): loss of consciousness with uncontrollable shaking Thoughts or actions of suicide Other symptoms include: Stomach cramps; trouble remembering or concentrating; diarrhea; feeling uneasy or restless; severe anxiety or panic-attacks; headache; sensitivity to light, noise or physical contact; shaking; vomiting; trouble sleeping; feeling irritable; muscle pain or stiffness; a burning or prickling feeling in the hands, arms, legs or feet; sweating. | |
If you or your child have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
pms-CLOBAZAM tablets should be stored in their original containers, between 15°C and 30°C.
Keep out of reach and sight of children.
If you want more information about pms-CLOBAZAM:
- Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling Pharmascience Inc. at 1-888-550-6060.
Pharmascience Inc.
Montreal, QC, Canada
H4P 2T4
www.pharmascience.com